Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT01809158
Eligibility Criteria:
Inclusion Criteria:
* Age 18-64 years
* Primary Axis I diagnosis (DSM-IV) of schizophrenia, any subtype
* The current episode should be either a relapse episode or a first onset schizophrenia and the duration of the relapse episode and first onset schizophrenia should be under five years
* Indication of treatment-resistance defined by failure of at least on adequate dose of antipsychotic medication (equivalent to chlorpromazine of 200 mg/day or more) given for at least four weeks. For the minority of patients receiving second generation antipsychotic medications, adequate doses will be Risperidone 4mg/day, or Olanzapine 10mg/day.
* Presence of at least moderate symptom severity measured according to the PANSS (score of at least 75)
* On adequate dose of antipsychotic medication at entry and throughout the trial period except during medication switch when participant may take lower doses
* Both genders, but women have to be of non-child bearing age because of potential risks to pregnant women, and the difficulty of ensuring contraception
Exclusion Criteria:
* Substance abuse co-morbidity or history of substance abuse/dependence within the previous three months
* Impaired cognitive capacity because of a degenerative brain condition or trauma or diagnosis of mental retardation
* Any serious medical condition that affects brain or cognitive function (e.g. epilepsy, serious head injury, brain tumor or other neurological and neurodegenerative conditions)
* Any clinically significant or unstable medical disorder as determined by the investigators that would preclude study participation, including congestive heart failure, abnormal liver function or disease, renal impairment. Also patients with leucopenia, anemia and thrombocytopenia will be excluded.
* History of hypersensitivity to tetracycline
* Patients on anticoagulant therapy
* Patients requiring ergot alkaloids
* Patients taking antacids containing aluminum, calcium or magnesium and iron containing products
* Women of childbearing age (age 18-49 years)
* Increased risk of suicide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01809158
Study Brief:
Protocol Section:
NCT01809158